High-dose Versus Low-dose Oral Ketamine on Control and Relapse of Treatment-resistant Depression: A Randomized, Double-blinded Clinical Trial
Gholamreza KheirAbadi, Shirin Golkar
Iranian Journal of Psychiatry and Behavioral Sciences December 20, 2023 DOI: 10.5812/ijpbs-137879 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized clinical trial Double-blind Peer reviewed |
|---|---|
| Sample size | 29 |
| Population | Patients with treatment-resistant depression |
| Intervention | Oral ketamine |
| Dose | 1 mg/kg or 2 mg/kg |
| Duration | Twice a week for six weeks, with follow-up at 2, 4, and 6 weeks during intervention and 1 week, 1 month, and 2 months after the end of the intervention |
| Measures | Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory-II (BDI-II) |
| Topics | Depression Esketamine Ketamine |
| Key findings | Low-dose (1 mg/kg) and high-dose (2 mg/kg) oral ketamine did not differ significantly in depression symptom change on the HDRS or BDI-II. The 2 mg/kg dose was associated with significantly more drowsiness and lightheadedness. The authors conclude that 1 mg/kg is preferred because of the adverse-effect profile, despite no conclusive efficacy difference. |
Abstract
Background: Treatment-resistant Depression (TRD) does not respond to conventional treatments. Despite the efforts made to control depression, the outcomes are controversial and inconclusive. New strategies such as ketamine use are accompanied by promising outcomes; however, the best dosage remains a question.
Objectives: The current study aimed to compare the effect of 1 and 2 mg/kg of oral ketamine in TRD subjects.
Methods: The current randomized clinical trial was conducted on 29 patients suffering from TRD. The patients were randomly assigned into two groups of treatment with low dose (1 mg/kg; n = 17) versus high dose (2 mg/kg; n = 12) oral ketamine twice a week for six weeks. The Hamilton Depression Rating Scale (HDRS) and the Beck Depression Inventory-II (BDI-II) were applied to assess the outcomes of the interventions at baseline, within 2, 4, and 6 weeks after the interventions, and then, within a week, a month, and 2 months after the end of the intervention.
Results: Baseline HRDS (P-value = 0.393) and BDI-II (P-value = 0.0.919) were similar in both groups. Neither HDRS (P-value = 0.97) nor BDI-II (P-value = 0.71) had a significant trend of changes when low versus high-dose ketamine uses were compared. The comparison of the frequency of ketamine-related adverse effects revealed a significantly higher incidence of drowsiness (P-value = 0.021) and lightheadedness (P-value = 0.004) in high-dose ketamine.
Conclusions: We achieved no conclusive superiority or efficacy of 1 mg/kg over 2 mg/kg of oral ketamine; however, considering the adverse effects, a 1 mg/kg dose is preferred.
Comparable studies
Other randomized controlled trials on ketamine for depression, most cited first.
Citations in the library
Cites 15
- A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression Archives of General Psychiatry August 1, 2006
- Antidepressant Efficacy of Ketamine in Treatment-Resistant Major Depression: A Two-Site Randomized Controlled Trial American Journal of Psychiatry August 28, 2013
- Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study American Journal of Psychiatry May 21, 2019
- Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) The International Journal of Neuropsychopharmacology July 9, 2019
- Management of Treatment-Resistant Depression: Challenges and Strategies Neuropsychiatric Disease and Treatment 2020
and 10 more in the library